23 results · 22ms · Sources: EU EUDAMED, US FDA

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Sontro® OTC Hearing Aids (AI)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

BD BBL™ Taxo™ Differentiation Discs for Nystatin

FDA UDI
BECTON, DICKINSON AND COMPANY·00382902315506·BD BBL™ Taxo™ Differentiation Discs for Nystati...

devemed

FDA UDI
devemed GmbH·04061644020867·Suture and membrane tweezers I = 2.2 mm, angled...

HEART SYNC

FDA 510(k)
FDA Class 3 ·Cardiovascular

REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE

FDA 510(k)
FDA Class 2 ·Cardiovascular

Reicodent

FDA UDI
devemed GmbH·04061644063208·Suture and membrane tweezers I = 2.2 mm, angle...

GRANUFLO

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

SM304 M-SERIES W/ZOOM

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·July 22, 2011

ACRYSOF

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·July 15, 2013

COBALT HV W/ GENTAMICIN POWDER BONE CEMENT 40 GRAMS

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LOD·October 2, 2017

COBALT HV W/ GENTAMICIN POWDER BONE CEMENT 40 GRAMS

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LOD·October 6, 2017

BD DIFCO PURPLE BROTH BASE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 25, 2021

EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

FDA Adverse Event
Injury ·AIZU OLYMPUS CO., LTD.·Product code FDS·November 25, 2025

ONCOLOGY SALVAGE SYSTEM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 10, 2017

ONCOLOGY SALVAGE SYSTEM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 10, 2017

2710 CLEARTRACE LT

FDA Adverse Event
Other ·CONMED CORPORATION·Product code GXY·April 13, 2007

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025